QUEBEC CITY, May 13 /PRNewswire-FirstCall/ - AEterna Zentaris Inc.
(NASDAQ: AEZS, TSX: AEZ), a global biopharmaceutical company focused on
endocrine therapy and oncology, today announced that the article titled
"Placebo-controlled dose-ranging Phase 2 study of subcutaneously
administered LHRH antagonist cetrorelix in patients with symptomatic benign
prostatic hyperplasia (BPH", has been accepted for publication in an
upcoming issue of the European Urology Journal. Written by F.M.J. Debruyne,
Department of Urology, Academic Hospital Nijmegen, The Netherlands, A.A.
Gres, Clinical Urology MOKB, Minsk, Belarus, and D.L. Arustamov, Center of
Urology, Ministry of Health of Republic of Uzbekistan, the article refers
to results of a Phase 2 trial with cetrorelix in BPH, which showed a
prolonged improvement in BPH symptoms and uroflow, persisting up to the end
of the 20-week observation period.

These results are part of previously disclosed Phase 2 data on
cetrorelix in BPH through prior abstracts and poster presentations. The
article is available online at http://www.europeanurology.com

Prof. Jurgen Engel, Ph.D., Executive Vice President, Scientific Affairs
at AEterna Zentaris commented, "We are very proud to have the work of Prof.
Debruyne and his colleagues on cetrorelix published in this prestigious
peer reviewed European journal. The article, along with the recent Best
Poster Presentation Award that Prof. Debruyne received last March at the
23rd Annual European Association of Urology Meeting, is another
acknowledgement of the quality of our development program with cetrorelix
in BPH."

THE ABSTRACT

Background and Objectives

Pilot studies with daily dosing suggested the use of the luteinizing
hormone-releasing hormone antagonist cetrorelix for the treatment of
symptoms from BPH. The objective was to assess efficacy and safety of three
dosing schemes of cetrorelix in patients with symptomatic BPH.

Trial Design

After a run-in period with four weekly injections of placebo, 140
patients with an international prostate symptoms score (I-PSS) >= 13 and a
peak urinary flow rate (PFR) 5-13 ml/s were randomly allocated to four
treatment groups. Patients received either cetrorelix at dosages of 5 mg/wk
x 4, 10 mg/wk x 2 or 10 mg/wk x 4 or placebo.

Main and secondary endpoints included I-PSS, PFR and mean uroflow,
residual urinary volume, prostate volume, plasma testosterone, quality of
life, and sexual function which were evaluated over a total of 20 weeks
after randomization.

Results

In all cetrorelix groups, a rapid improvement in mean I-PSS was
obtained, with a peak effect of -5.4 to -5.9 (placebo: -2.8). After all
dosages of cetrorelix given, changes from baseline and differences to
placebo were statistically significant up to week 20. Similarly, secondary
parameters showed a significant, rapid, and persistent improvement for all
cetrorelix dosages. All dosage regimens were well tolerated. The study
evaluated a single treatment course only; further studies with repeated
treatment courses will be required to establish a dose regimen for
long-term disease management.

Conclusions

In summary, the trial showed a rapid onset in improvement of I-PSS,
urinary symptoms and quality of life, accompanied by a slight reduction in
prostate size with a short course therapy with cetrorelix. The improvement
lasted well beyond the dosing period. This should, therefore, allow for the
development of intermittent dosage regimens of cetrorelix with two or three
treatment courses per year, thus relieving concerns about treatment
compliance with drugs requiring daily dosing.

About Cetrorelix

Cetrorelix is part of AEterna Zentaris' LHRH antagonist therapeutic
approach that has demonstrated in Phase 2 studies to provide fast and
long-lasting relief of BPH symptoms while being well tolerated, with a low
incidence of sexual side effects. Cetrorelix peptide-based drugs were
developed by the Company in cooperation with Nobel Prize winner Prof.
Andrew Schally, currently of the U.S. Veterans Administration in Miami.

Cetrorelix acetate is marketed under the brand name Cetrotide(R), the
first LHRH antagonist approved for therapeutic use as part of in vitro
fertilization programs (controlled ovarian stimulation/assisted
reproductive technologies) in Europe, the U.S. and Japan. It was launched
on the market through Serono (now Merck Serono) in the United States,
Europe and in several other countries, as well as in Japan through
Shionogi.

About the Cetrorelix Phase 3 Program in BPH

Cetrorelix pamoate is being studied in three Phase 3 trials which will
include approximately 1,500 men with symptomatic BPH in the United States,
Canada and Europe. One Phase 3 efficacy trial, primarily in the United
States and Canada and with additional sites in Europe, involves
approximately 600 patients (which are fully enrolled) and is being led by
Herbert Lepor, M.D., Professor and Martin Spatz Chairman of Urology, New
York University School of Medicine, New York. In the trial, patients enter
a no-treatment run-in observation period to confirm severity and stability
of voiding symptoms based on the International Prostate Symptom Score
(I-PSS). Patients are then randomly allocated to cetrorelix or placebo in a
double-blind fashion. Patients are administered cetrorelix by
intra-muscular (IM) injection at Week 0, 2, 26 and 28 and are followed up
to Week 52. Then, in an open-label extension, patients will receive
cetrorelix by IM injection at Week 52, 54, 78 and 80 will be followed up to
Week 90.

A second, similarly designed ongoing multi-center Phase 3 efficacy
study, being led by Prof. Frans M.J. Debruyne, M.D., Ph.D., from The
Netherlands, will enroll approximately 400 patients in Europe. The third
Phase 3 trial currently screening patients, is an open-label, single-armed
multi-center safety study involving approximately 500 patients in both
North America and Europe, and is being led by Joel Kaufman, M.D., Associate
Clinical Professor of Urology, University of Colorado School of Medicine,
Denver, Colorado, and Urology Research Options, Aurora, Colorado.

The primary endpoint for both North American and European efficacy
studies is the change in I-PSS between baseline and Week 52. Other efficacy
endpoints include additional measures of BPH-symptom progression and the
need for BPH-related surgery. Safety endpoints include changes in sexual
function. Other important endpoints include plasma changes in levels of
testosterone, and assessment of other adverse events.

The cetrorelix Phase 3 program is based on comprehensive clinical
practice guidelines to ensure quality control, including input from expert
advisors on study design, publishing results in peer-reviewed journals and
discussion of the studies with regulatory agencies.

Benign Prostatic Hyperplasia

Benign prostatic hyperplasia (BPH) is one of the most common diseases
of aging men - affecting more than 20 million men in the United States -
but its etiology is far from being completely understood. Data from ongoing
research suggest BPH and its associated lower urinary tract symptoms (LUTS)
are more complex conditions than once thought. While previous research on
BPH etiology tended to focus on testosterone and other hormones, more
recent research suggests other factors may play a greater role in the
development of BPH and LUTS - including inflammation, various growth
factors, and adrenoreceptors.

BPH-associated LUTS include frequent urination and/or urgent need to
urinate, waking at night to urinate (nocturia), difficulty starting
urination and/or weak urinary stream, and feeling that the bladder is not
completely empty after urination. While current therapies provide some
efficacy in BPH they are often associated with troublesome sexual side
effects.

About AEterna Zentaris Inc.

AEterna Zentaris Inc. is a global biopharmaceutical company focused on
endocrine therapy and oncology, with proven expertise in drug discovery,
development and commercialization.
News releases and additional information are available at http://www.aezsinc.com.

Forward-Looking Statements

This press release contains forward-looking statements made pursuant to
the safe harbor provisions of the U.S. Securities Litigation Reform Act of
1995. Forward-looking statements involve known and unknown risks and
uncertainties, which could cause the Company's actual results to differ
materially from those in the forward-looking statements. Such risks and
uncertainties include, among others, the availability of funds and
resources to pursue R&D projects, the successful and timely completion of
clinical studies, the ability of the Company to take advantage of business
opportunities in the pharmaceutical industry, uncertainties related to the
regulatory process and general changes in economic conditions. Investors
should consult the Company's quarterly and annual filings with the Canadian
and U.S. securities commissions for additional information on risks and
uncertainties relating to the forward-looking statements. Investors are
cautioned not to rely on these forward-looking statements. The Company does
not undertake to update these forward-looking statements. We disclaim any
obligation to update any such factors or to publicly announce the result of
any revisions to any of the forward-looking statements contained herein to
reflect future results, events or developments except if we are requested
by a governmental authority or applicable law.

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